The DART-AD trial – a randomised controlled trial to compare the progression of cognitive impairment in dementia patients continuing to take or discontinued from treatment with neuroleptics (antipsychotic drugs)
Ed Juszczak and Ly-Mee Yu with groups in two regions headed by Robin Jacoby and Rupert McShane (Midlands and South West), Clive Ballard (London) and John O’Brien (North East & Edinburgh).
More than 40% of people with dementia living in residential or nursing home care, and many living in their own homes, are prescribed neuroleptic drugs, usually as a pharmacological treatment for behavioural and psychiatric symptoms. There is accruing evidence, however, from preliminary and cross-sectional studies, that these agents may accelerate cognitive decline. It is imperative to investigate this issue further, as current medical management may be causing a considerable amount of harm and may speed up the progression of the dementia. The potentially harmful effects of these agents cannot be assumed from the currently available evidence, and well-designed prospective studies are needed. Simple changes in current practice might benefit hundreds of thousands of people with dementia in the UK alone.
DART-AD is a multi-centre randomised double-blind placebo-controlled two-arm parallel group trial to compare the progression of cognitive impairment in dementia patients continuing to take or discontinued from neuroleptic treatment. The hypothesis being tested is that continued treatment with neuroleptic agents will be associated with an accelerated rate of cognitive decline in dementia patients, assessed at 6 and 12 months follow-up on a number of standardised outcome measures (primary outcome: Severe Impairment Battery). Patients already taking a neuroleptic for behavioural or psychiatric disturbance in dementia will be randomised to continue their current neuroleptic or to discontinue treatment and transfer to placebo. The study will answer key questions regarding the impact of neuroleptic drugs upon cognitive performance, in a rigorous design that builds upon previous prospective dementia studies in Newcastle and Oxford.
Recruitment commenced in October 2001.
